Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In a previous study by Dr. Calkin, the principal investigator of this study, persons with bipolar disorder and either type II diabetes or insulin resistance were found to experience more severe symptoms of bipolar illness and a lower response to treatment, compared to persons with bipolar disorder who did not have type II diabetes or insulin resistance. To further explore these findings, the investigators have developed this study to see if treating insulin resistance (using metformin, a drug used to improve the body's use of insulin) may also help improve the symptoms of bipolar illness.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cynthia Calkin
• Collaborator: Stanley Medical Research Institute
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. diagnosis of BD I or II

3. non-remitting BD as defined by the presence of mood symptoms of at least moderate severity, indicated by a MADRS score ≥ 15 despite being on optimal treatment according to the CANMAT/APA guidelines

4. HOMA-IR ≥ 1.8, indicating IR (subjects will have FPG and FSI testing done to determine whether they have IR or T2D)

5. current episode of depression 4 weeks or longer in duration

6. on a stable optimal dose of mood stabilizing treatment for at least 4 weeks prior to study entry

Exclusion Criteria:

1. Diagnoses of organic mood disorder, mood disorder not otherwise specified, alcohol dependence, T1D or T2D

2. presence of rapid cycling (by DSM-5 criteria), mania, (indicated by a Young Mania Rating Scale [YMRS] score > 15), or suicide ideation (current score of 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating scale [C-SSRS])

3. patient receiving metformin < 2 weeks prior to study entry

4. metformin allergy or sensitivity

5. metformin contraindicated where liver function tests > three times the upper limit of normal, estimated glomerular filtration rate (eGFR) < 30, CBC revealing megaloblastic anemia or pre-existing untreated B12 deficiency

6. pregnancy or breastfeeding

7. lactose intolerance, diagnosed by a physician

8. chronic use of narcotic medications

9. patient lacks full capacity to consent to study participation.